MOHANA RAO KANCHARANA
Boston,MA
Summary
Quality-driven compliance analyst with expertise in tracking, documentation, and reporting requirements. Proficient in evaluating work materials and procedures to identify improvement opportunities and suggest necessary adjustments for ongoing compliance. Highly motivated with a proactive approach, committed to delivering exceptional outcomes and contributing to organizational achievements.
Overview
3
3
years of professional experience
Work History
Intern
MH Com-Biotic Inc
04.2024 - 06.2024
- Planned and prepared 510k documentation for the ComBatic hydrogel/spray, prioritizing regulatory compliance and optimizing wound treatment effectiveness
- Reviewed 510(k) documentation for accuracy and regulatory compliance while managing design control activities to ensure FDA alignment
- Managed labeling operations to maintain consistency and adherence to FDA standards across all product materials
Regulatory and Compliance Specialist | Intern
Falmouth Pharma LLC
07.2023 - 01.2024
- Worked as a Regulatory and Compliance Specialist intern, helping to design and implement a risk-based reporting and compliance monitoring program.
- Performed regular compliance reviews, set goals, evaluated results, and presented findings to management.
- Used Liberty software to track regulatory requirements, manage compliance documentation, and assist with audits.
- Achievements include improving quality processes, analyzing privacy incidents, and streamlining communication with regulatory agencies to promote a more efficient and ethical compliance environment.
Quality Assurance Officer
Darwin Formulations PVT LTD
09.2021 - 08.2022
- Proficient in creating SOPs, STPs, and other essential documentation for pharmaceutical formulations, ensuring clarity and compliance with industry standards.
- Experienced in compiling detailed Master Formula Records (MFRs) and maintaining accurate, comprehensive log sheets for operational efficiency.
- Skilled in managing documentation for inspections and audits, with a strong focus on quality assurance activities that uphold regulatory standards within pharmaceutical environments.
Quality Control Intern
Green Park Pharmaceutical Private Limited
08.2021 - 09.2021
- Ensured tablet manufacturing processes adhered to industry and company standards by conducting inspections, performing tests, and managing documentation to maintain high-quality standards.
- Assisted in implementing ISO 9001:2015 quality management system standards, ensuring compliance with regulatory and customer requirements.
- Collaborated with estimators and project managers to collect information and perform cost calculations for project planning and execution.
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, MA06.2024
Skills
Excellent Documentation Skills (510k premarket notification)
Privacy and Security Compliance
Regulatory Knowledge
Regulatory Reporting
Research Skills
Risk Management
Skilled in Liberty software
Strong writing and verbal communication skills
Timeline
Intern
MH Com-Biotic Inc
04.2024 - 06.2024
Regulatory and Compliance Specialist | Intern
Falmouth Pharma LLC
07.2023 - 01.2024
Quality Assurance Officer
Darwin Formulations PVT LTD
09.2021 - 08.2022
Quality Control Intern
Green Park Pharmaceutical Private Limited
08.2021 - 09.2021
Master of Science - Regulatory Affairs
Northeastern University
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